Actively Recruiting
Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
Led by AstraZeneca · Updated on 2026-06-01
200
Participants Needed
116
Research Sites
106 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children aged 6 to under 18 years who have severe eosinophilic asthma. This study focuses on patients with a history of asthma attacks and uncontrolled symptoms despite using high-dose inhaled corticosteroids and at least one additional asthma controller medication. The study is a Phase III, randomized, double-blind, placebo-controlled trial designed to measure the time to first asthma exacerbation. The study includes a screening period lasting between 4 to 12 weeks to determine eligibility. Participants are randomly assigned to receive either benralizumab or a placebo injection during the double-blind treatment period, which lasts at least 16 weeks or until an asthma exacerbation occurs. Those who experience an exacerbation during this period may continue treatment in an open-label extension phase lasting at least 48 weeks, followed by an end-of-treatment visit 8 weeks after the last dose. During the study, participants will have regular visits for assessments including asthma control questionnaires, symptom scoring, lung function tests, and blood tests for benralizumab levels and antibodies. Researchers will monitor asthma exacerbations, medication use, night-time awakenings, and quality of life measures. Safety and treatment adherence will be closely observed throughout the study and the extension period, with total participation lasting over a year depending on individual progress.
CONDITIONS
Brief Title
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give assent and have caregiver provide written consent before any study procedures
- Willing and able to answer study questionnaires
- Male or female aged 6 to under 18 years
- Diagnosed with severe eosinophilic asthma for at least 12 months
- Severe asthma diagnosis confirmed and managed for at least 6 months prior to Visit 1
- History of asthma exacerbations requiring systemic corticosteroids or hospitalization within 12 months prior to Visit 1, or 2 exacerbations per year within 2 years prior plus stable oral corticosteroids or hospitalization
- On stable high-dose inhaled corticosteroids plus at least one additional controller medication for at least 6 months
- Eosinophilic airway inflammation indicated by blood eosinophil count ≥300 cells/µL or 150-299 with documented elevated eosinophils from other tests
- At least 70% compliance with maintenance asthma medication during screening
- At least 50% completion of asthma symptom diaries during screening
- Asthma Control Questionnaire score ≥1.5 at screening and Visit 2a
- Body weight ≥15 kg
- Females of childbearing potential must use effective contraception if sexually active
You will not qualify if you...
- Pulmonary or systemic diseases other than asthma that cause elevated eosinophils
- Life-threatening asthma
- Asthma exacerbation requiring systemic corticosteroids or increased oral corticosteroids within 2 weeks before Visit 2a
- Acute respiratory infection requiring antibiotics or antivirals within 2 weeks before first dose
- Unstable medical conditions affecting safety or study participation
- History of anaphylaxis to biologic therapy
- Current or past malignancy
- Helminth parasitic infection
- Use of immunosuppressive medication
- Receipt of immunoglobulin or blood products within 30 days before Visit 1
- Receipt of any biologic therapy within five half-lives before Visit 2
- Previous treatment with benralizumab
- Participation in another interventional clinical study
- Known hypersensitivity to benralizumab or its ingredients
- Currently pregnant, breastfeeding, or lactating
- Previous randomisation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 12 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits including screening and enrollment visits
Duration - At least 16 weeks, variable depending on when the first asthma exacerbation occurs
Participants receive either benralizumab or placebo via subcutaneous injection during the double-blind treatment period. Treatment continues until the first asthma exacerbation or until the study's required number of events occur.
Visits at baseline and regular visits approximately every 8 weeks during treatment
Duration - At least 48 weeks
Participants who experience an asthma exacerbation during the double-blind period may continue treatment with benralizumab in an open-label extension period.
Regular visits during the open-label extension period, including an end-of-treatment visit 8 weeks after the last dose
Duration - 8 weeks after last dose
Participants have an end-of-treatment visit to assess safety and outcomes after completing the open-label extension treatment period.
1 visit (in-person)
Trial Site Locations
Total: 116 locations
1
Research Site
Mobile, Alabama, United States, 36608
Withdrawn
2
Research Site
Montgomery, Alabama, United States, 36106
Withdrawn
3
Research Site
Tucson, Arizona, United States, 85724
Actively Recruiting
4
Research Site
Little Rock, Arkansas, United States, 72202
Withdrawn
5
Research Site
Madera, California, United States, 93636
Withdrawn
6
Research Site
Torrance, California, United States, 90505
Actively Recruiting
7
Research Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
8
Research Site
Miami, Florida, United States, 33144
Actively Recruiting
9
Research Site
Miami, Florida, United States, 33184
Actively Recruiting
10
Research Site
Ocala, Florida, United States, 34471
Completed
11
Research Site
Owensboro, Kentucky, United States, 42301
Actively Recruiting
12
Research Site
Lafayette, Louisiana, United States, 70508
Actively Recruiting
13
Research Site
New Orleans, Louisiana, United States, 70112
Withdrawn
14
Research Site
Glenn Dale, Maryland, United States, 20769
Actively Recruiting
15
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
16
Research Site
Ridgeland, Mississippi, United States, 39157
Withdrawn
17
Research Site
Kansas City, Missouri, United States, 64108
Completed
18
Research Site
Lincoln, Nebraska, United States, 68510
Withdrawn
19
Research Site
Brick, New Jersey, United States, 08724
Withdrawn
20
Research Site
Northfield, New Jersey, United States, 08225
Actively Recruiting
21
Research Site
The Bronx, New York, United States, 10459
Actively Recruiting
22
Research Site
Cincinnati, Ohio, United States, 45229
Actively Recruiting
23
Research Site
Cleveland, Ohio, United States, 44106
Actively Recruiting
24
Research Site
Charleston, South Carolina, United States, 29425
Completed
25
Research Site
Dallas, Texas, United States, 75235
Withdrawn
26
Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
27
Research Site
Tyler, Texas, United States, 75708
Actively Recruiting
28
Research Site
Morgantown, West Virginia, United States, 26506
Withdrawn
29
Research Site
Ciudad de Buenos Aires, Argentina, C1414AIF
Actively Recruiting
30
Research Site
Ciudad de Buenos Aire, Argentina, C1425DTG
Actively Recruiting
31
Research Site
Florida, Argentina, B1602DQD
Actively Recruiting
32
Research Site
Lobos, Argentina, 7240
Actively Recruiting
33
Research Site
Mar del Plata, Argentina, B7600
Actively Recruiting
34
Research Site
Mendoza, Argentina, 5500
Actively Recruiting
35
Research Site
Mendoza, Argentina, M5500CCG
Actively Recruiting
36
Research Site
Rosario, Argentina, 2000
Actively Recruiting
37
Research Site
San Juan Bautista, Argentina, 1888
Actively Recruiting
38
Research Site
Santa Fe, Argentina, S3000ASF
Actively Recruiting
39
Research Site
Edmonton, Alberta, Canada, T6G 1C9
Actively Recruiting
40
Research Site
Burlington, Ontario, Canada, L7L 6W6
Withdrawn
41
Research Site
Hamilton, Ontario, Canada, L8S 1G5
Withdrawn
42
Research Site
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
43
Research Site
Québec, Quebec, Canada, G1V 4W2
Withdrawn
44
Research Site
Créteil, France, 94010
Actively Recruiting
45
Research Site
Lyon, France, 69394
Actively Recruiting
46
Research Site
Montpellier, France, 34295
Actively Recruiting
47
Research Site
Nice, France, 06000
Actively Recruiting
48
Research Site
Paris, France, 75019
Withdrawn
49
Research Site
Rouen, France, 76031
Actively Recruiting
50
Research Site
Toulouse, France, 31059
Actively Recruiting
51
Research Site
Essen, Germany, 41469
Withdrawn
52
Research Site
Wesel, Germany, 46483
Withdrawn
53
Research Site
Belagavi, India, 590019
Not Yet Recruiting
54
Research Site
Bikaner, India, 334003
Not Yet Recruiting
55
Research Site
Hanamkonda, India, 506004
Not Yet Recruiting
56
Research Site
Jaipur, India, 302017
Not Yet Recruiting
57
Research Site
Jaipur, India, 302020
Not Yet Recruiting
58
Research Site
Kolhāpur, India, 416007
Not Yet Recruiting
59
Research Site
Ludhiana, India, 141002
Not Yet Recruiting
60
Research Site
Nagpur, India, 441108
Not Yet Recruiting
61
Research Site
Nellore, India, 524004
Not Yet Recruiting
62
Research Site
Pune, India, 411047
Not Yet Recruiting
63
Research Site
Raipur, India, 492014
Not Yet Recruiting
64
Research Site
Sheikhpura, India, 800014
Not Yet Recruiting
65
Research Site
Genova, Italy, 16100
Actively Recruiting
66
Research Site
Milan, Italy, 20142
Actively Recruiting
67
Research Site
Pavia, Italy, 27100
Actively Recruiting
68
Research Site
Ponte San Pietro, Italy, 24036
Actively Recruiting
69
Research Site
Roma, Italy, 00161
Withdrawn
70
Research Site
Roma, Italy, 00165
Actively Recruiting
71
Research Site
Verona, Italy, 37134
Withdrawn
72
Research Site
Bialystok, Poland, 15-879
Actively Recruiting
73
Research Site
Krakow, Poland, 31-624
Actively Recruiting
74
Research Site
Lodz, Poland, 90-302
Actively Recruiting
75
Research Site
Rzeszów, Poland, 35-612
Actively Recruiting
76
Research Site
Skarżysko-Kamienna, Poland, 26-110
Active, Not Recruiting
77
Research Site
Tarnów, Poland, 33-100
Actively Recruiting
78
Research Site
Belgrade, Serbia, 11000
Not Yet Recruiting
79
Research Site
Belgrade, Serbia, 11040
Withdrawn
80
Research Site
Belgrade, Serbia, 11070
Not Yet Recruiting
81
Research Site
Kragujevac, Serbia, 34000
Withdrawn
82
Research Site
Novi Sad, Serbia, 21000
Not Yet Recruiting
83
Research Site
Bellville, South Africa, 7530
Not Yet Recruiting
84
Research Site
Benoni, South Africa, 1500
Not Yet Recruiting
85
Research Site
Cape Town, South Africa, 7700
Not Yet Recruiting
86
Research Site
Centurion, South Africa, 0157
Not Yet Recruiting
87
Research Site
Durban, South Africa, 3630
Withdrawn
88
Research Site
Durban, South Africa, 4001
Not Yet Recruiting
89
Research Site
Durban, South Africa, 4092
Withdrawn
90
Research Site
Germiston, South Africa, 1401
Not Yet Recruiting
91
Research Site
Krugersdorp, South Africa, 1739
Not Yet Recruiting
92
Research Site
Lenasia, South Africa, 1827
Not Yet Recruiting
93
Research Site
Pietermaritzburg, South Africa, 3201
Not Yet Recruiting
94
Research Site
Cheongju-si, South Korea, 28644
Completed
95
Research Site
Junggu, South Korea, 22332
Actively Recruiting
96
Research Site
Seoul, South Korea, 03080
Actively Recruiting
97
Research Site
Seoul, South Korea, 03722
Actively Recruiting
98
Research Site
Seoul, South Korea, 05505
Completed
99
Research Site
Badalona, Spain, 08916
Actively Recruiting
100
Research Site
Barcelona, Spain, 8035
Actively Recruiting
101
Research Site
Benalmádena, Spain, 29631
Actively Recruiting
102
Research Site
Cartagena, Spain, 30203
Actively Recruiting
103
Research Site
Esplugues de Llobregat, Spain, 8950
Actively Recruiting
104
Research Site
Madrid, Spain, 28034
Actively Recruiting
105
Research Site
Mérida, Spain, 06800
Withdrawn
106
Research Site
Valencia, Spain, 46026
Actively Recruiting
107
Research Site
Changhua, Taiwan, 500
Actively Recruiting
108
Research Site
Kaohsiung City, Taiwan, 833
Actively Recruiting
109
Research Site
Taichung, Taiwan, 402
Actively Recruiting
110
Research Site
Taipei, Taiwan, 100
Actively Recruiting
111
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
112
Research Site
Glasgow, United Kingdom, G3 8SJ
Withdrawn
113
Research Site
Leicester, United Kingdom, LE2 7LZ
Withdrawn
114
Research Site
London, United Kingdom, E1 4NS
Actively Recruiting
115
Research Site
London, United Kingdom, SE5 9RS
Actively Recruiting
116
Research Site
Manchester, United Kingdom, M13 9PL
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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